PMA P060008S063
- Device
- Taxus Liberte Monorail & Otw Paclitaxel-eluting Co
- Applicant
- Boston Scientific Corp.
- PMA number
- P060008
- Supplement
- S063
- Decision date
- 2011-01-14
Current openFDA PMA Record
- Device
- TAXUS LIBERTE MONORAIL & OTW PACLITAXEL-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P060008
- Supplement
- S063
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2011-01-14
- Decision code
- OK30
- Date received
- 2010-12-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- SOFTWARE UPGRADE TO PROCESS EQUIPMENT.